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临床试验/NCT06803797
NCT06803797已完成不适用

A Behavior Change Technique (BCT) Intervention to Develop a Walking Habit Among Caregivers for Persons With Alzheimer's Disease (AD) or Alzheimer's Disease Related Dementias (ADRD)

Northwell Health2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年3月18日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
Binary indicator of habit formation

研究概览

简要总结

This 12-week trial will test the efficacy of a multi-component, personalized text-message delivered behavior change technique (BCT) intervention to encourage habitual physical activity (defined as regular walking of 1,000 or more steps during a one-hour period on 7 consecutive days according to a personalized walking plan) among care providers of persons with AD/ADRD via the key mechanism of behavior change (MoBC) of automaticity.

The main question it aims to answer whether a multi-component, personalized BCT intervention to increase a walking habit of 1,000 steps/day will lead to successful development of habitual walking among 60 percent of caregivers enrolled.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Identify as a caregiver (formal/paid or informal/unpaid) for persons with Alzheimer's Disease or Alzheimer's Disease Related Dementias (AD/ADRD)
  • Age >=18 and <=85
  • Speak English or Spanish as primary language
  • Self-report low levels of physical activity or walking

排除标准

  • Individuals who self-report having been informed by a clinician it is medically or physically unsafe to engage in a walking intervention
  • Does not own or cannot regularly access a smartphone capable of receiving text messages or accessing the internet
  • Does not own or have access to an email address
  • Lives outside the United States

研究组 & 干预措施

Intervention

Experimental

This will be a 12-week, single-arm, multi-component, personalized BCT intervention. We will provide participants with 4 BCTs daily (Goal Setting, Action Planning, Self-Monitoring, and Prompt/Cue) that have been associated with habit formation theory and development of physical activity habits in prior research.

干预措施: Behavior Change Technique Package (Behavioral)

结局指标

主要结局

Binary indicator of habit formation

时间窗: Baseline to intervention period (12 weeks)

Binary indicator of habit formation, defined as a daily walking habit of 1,000 steps during a pre-determined period identified during baseline. Assessing the efficacy of the personalized BCT intervention by testing the null hypothesis of habit formation rate equal to 40% using a 1-sample binomial test at the 5% level 2-sided. Rate of habit formation will be summarized using the observed proportion, along with a 95% confidence interval.

次要结局

  • Habit formation association with changes in automaticity(Baseline (first 2 weeks of study) and last 2 weeks of intervention)
  • Longitudinal association between automaticity and habitual walking over time(Baseline to intervention period (12 weeks))
  • Heterogeneity of treatment effects for habit formation and on changes in automaticity(Baseline to intervention period (12 weeks))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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